Rheumatoid Arthritis Drug Development Solutions
There remains a significant unmet need in the treatment of rheumatoid arthritis (RA): there is no cure, treatments are often inconvenient and expensive, and safety is still a concern. Covance understands the challenges faced in RA clinical development, and has the insight and experience to help you achieve success.
Understanding rheumatoid arthritis industry demands
A trend towards more aggressive treatment under the 'treat to target' strategy
Steady market growth due in part to aging population
Movement towards early diagnosis and treatment of patients
Expanded range of treatment options including novel biologics and small molecules
Increasing availability of biosimilars making biologic treatments more accessible
Biosimilars to infliximab, etanercept and adalimumab all approved
The nature of RA trials and the current development landscape cause a number of challenges in many RA clinical development programs. Covance has developed solutions to overcome each of these and help you along the path to success.
RA drug development pain points.
- Competitive biologics marketplace
- Difficulty in identifying investigators and locating patients
- Suboptimal patient retention over long trial periods
- Inefficient trial design, eligibility creep and inconsistencies in both subjective and objective trial outcomes
- Increasing demand for patients due to a small percentage participating in trials
- Inconsistencies in trial outcomes, which may be linked to inappropriate or incorrect use of PRO measures
- Inefficient patient recruitment, often a result of the competitive RA trial environment
- Delays if sites are unable to recruit the number of patients required in a timely manner
Extensive experience in rheumatoid arthritis clinical trials.
- Since 2012 Covance has managed 30 RA studies with 919 sites and 2,796 patients
- Proven experience in meeting RA trial timelines
- We have performance metrics on more than 1,400 rheumatologists
- Covance employ more than 1,200 RA-experienced staff, including more than 530 clinical research associates and nearly 150 project managers
Through our extensive experience in RA clinical trials we have accrued the operational and scientific expertise, along with the necessary infrastructure, to help you meet timelines and save costs in your RA clinical development program.
We know how to address the pain points of RA clinical trials.
Optimize study planning and speed patient enrollment with evidence-based approaches
Clinical knowledgebase housing more than 40% global clinical trial data at any one time
Target patient populations for efficient recruitment
- Clinical trial opt-in patient initiative* currently with more than 2,570 RA patients
- Incorporating global disease prevalence data to identify target patient populations
- Performance metrics on more than 1,400 Ph II–III RA investigators since 2012
- All RA study recruitment timelines achieved since 2012
- Specialty inflammatory biomarkers, e.g., GlycA, rheumatoid factor and hCRP
Identify and validate relevant biomarkers
- Flexible biomarker team offering feasibility, development, validation and production expertise
- More than 550 assays available in-house
Improve patient retention through education and support
- Established patient support system, including health education and appointment reminders
- Covance voice of patient insights used in trial design to ensure patient-centric trials
Develop biosimilars to compete in current environment
- Integrated biosimilars solutions team
- Covance has supported the development of 107 unique biosimilars in 178 individual projects since 2010
Optimize product pricing for successful market entry
Dedicated market access team experienced in demonstrating real-world value and ensuring optimal reimbursement, having supported numerous inflammation products globally